Regulatory Postmarket Compliance Expert

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $180,000
Job Opportunity

Seeking an experienced Regulatory Postmarket Compliance professional to provide leadership and guidance on regulatory activities that safeguard products once they are on the market.

Responsibilities:
  • Lead and coordinate regulatory responses to postmarket events, ensuring compliance with global requirements.
  • Develop and manage submissions, reports, and notifications to regulatory health authorities.
  • Ensure accurate and timely documentation of reportable events in partnership with cross-functional teams.
  • Prepare and submit regulatory submissions and notifications.
  • Maintain traceability across regulatory reports.
  • Monitor submission progress and support follow-up actions and corrective actions.
  • Contribute to risk assessments, linking complaint data, regulatory trends, and findings.
  • Interpret evolving postmarket regulations and standards.
  • Provide strategic guidance to stakeholders on regulatory implications.
Requirements:
  • Bachelor's degree in a relevant field.
  • Minimum 6 years of experience in Regulatory Affairs or Quality Assurance in a regulated environment.
  • Demonstrated expertise in postmarket regulatory functions.
  • Strong technical writing and documentation skills.
  • Proven ability to work cross-functionally on risk, complaints, or field actions.

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